Application Nr Approved Date Route Status External Links
ANDA065283 2007-09-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Clarithromycin For Oral Suspension, Usp Is Indicated For The Treatment Of Mild To Moderate Infections Caused By Susceptible Isolates Of The Designated Bacteria In The Conditions As Listed Below: Adults Pharyngitis/tonsillitis Due To Streptococcus Pyogenes (the Usual Drug Of Choice In The Treatment And Prevention Of Streptococcal Infections And The Prophylaxis Of Rheumatic Fever Is Penicillin Administered By Either The Intramuscular Or The Oral Route. Clarithromycin Is Generally Effective In The Eradication Of S. Pyogenes From The Nasopharynx; However, Data Establishing The Efficacy Of Clarithromycin In The Subsequent Prevention Of Rheumatic Fever Are Not Available At Present.) Acute Maxillary Sinusitis Due To Haemophilus Influenzae , Moraxella Catarrhalis , Or Streptococcus Pneumoniae Acute Bacterial Exacerbation Of Chronic Bronchitis Due To Haemophilus Influenzae , Haemophilus Parainfluenzae , Moraxella Catarrhalis , Or Streptococcus Pneumoniae Community-Acquired Pneumonia Due To Haemophilus Influenzae , Mycoplasma Pneumoniae , Streptococcus Pneumoniae , Or Chlamydia Pneumoniae (twar). Uncomplicated Skin And Skin Structure Infections Due To Staphylococcus Aureus , Or Streptococcus Pyogenes (abscesses Usually Require Surgical Drainage.) Disseminated Mycobacterial Infections Due To Mycobacterium Avium , Or Mycobacterium Intracellulare In Patients Who Fail Therapy, Susceptibility Testing Should Be Done If Possible. If Resistance To Clarithromycin Is Demonstrated, A Non-Clarithromycin-Containing Therapy Is Recommended. (for Information On Development Of Resistance See Microbiology Section.) The Eradication Of H. Pylori Has Been Demonstrated To Reduce The Risk Of Duodenal Ulcer Recurrence. Children Pharyngitis/tonsillitis Due To Streptococcus Pyogenes Community-Acquired Pneumonia Due To Mycoplasma Pneumoniae , Streptococcus Pneumoniae , Or Chlamydia Pneumoniae (twar) Acute Maxillary Sinusitis Due To Haemophilus Influenzae , Moraxella Catarrhalis , Or Streptococcus Pneumoniae Acute Otitis Media Due To Haemophilus Influenzae , Moraxella Catarrhalis , Or Streptococcus Pneumoniae Note: For Information On Otitis Media, See Clinical Studies: Otitis Media. Uncomplicated Skin And Skin Structure Infections Due To Staphylococcus Aureus , Or Streptococcus Pyogenes (abscesses Usually Require Surgical Drainage.) Disseminated Mycobacterial Infections Due To Mycobacterium Avium , Or Mycobacterium Intracellulare Prophylaxis Clarithromycin For Oral Suspension, Usp Is Indicated For The Prevention Of Disseminated Mycobacterium Avium Complex (mac) Disease In Patients With Advanced Hiv Infection. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Clarithromycin And Other Antibacterial Drugs, Clarithromycin For Oral Suspension, Usp Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
3. Hypromelloses HYPROMELLOSES Unresolved
4. Maltodextrin MALTODEXTRIN Unresolved GRAS-Generally recognized as safe.
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Potassium Sorbate POTASSIUM SORBATE Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
8. Povidones POVIDONES Unresolved
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clarithromycin CLARITHROMYCIN ZINC85534098

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